Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-03-22 @ 1:37 PM
Study NCT ID:
NCT01972568
Status:
COMPLETED
Last Update Posted:
2018-01-02
First Post:
2013-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ukraine']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524618', 'term': 'TACI receptor-IgG Fc fragment fusion protein'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Merck KGaA Communication Center', 'organization': 'Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.', 'otherNumAtRisk': 102, 'otherNumAffected': 83, 'seriousNumAtRisk': 102, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.', 'otherNumAtRisk': 104, 'otherNumAffected': 84, 'seriousNumAtRisk': 104, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.', 'otherNumAtRisk': 100, 'otherNumAffected': 72, 'seriousNumAtRisk': 100, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mitral valve prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Right ventricular dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac valve vegetation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Endocarditis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Infective aortitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymph node abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ophthalmic herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinusitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Temporal lobe epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '44.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1208', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '0.89', 'ciUpperLimit': '2.72', 'statisticalMethod': 'Logistic regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\\<10 % increase, defined as \\<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \\<=1 (defined as no more than one) new BILAG B organ domain score.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '18.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone \\>20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here "Number of Participants Analyzed" signifies those subjects whose CS dose \\>=10 mg at Screening.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'title': 'Very much or much improved', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '46.0', 'groupId': 'OG002'}]}]}, {'title': 'Minimally improved or no change or minimally worse', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}, {'value': '46.0', 'groupId': 'OG002'}]}]}, {'title': 'Much or very much worse', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '6.0', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.'}, {'type': 'SECONDARY', 'title': 'Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.64', 'spread': '6.106', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '4.653', 'groupId': 'OG001'}, {'value': '-1.89', 'spread': '5.588', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Week 24', 'description': 'Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.', 'unitOfMeasure': 'mg per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to First SRI Response During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '16.7'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '16.4'}, {'value': '16.1', 'groupId': 'OG002', 'lowerLimit': '12.1', 'upperLimit': '20.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 24 Weeks', 'description': "SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\\<10 % increase, defined as \\<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \\<=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}, {'value': '49.0', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and \\<=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by \\<10% (defined as \\<0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000'}, {'value': '80.8', 'groupId': 'OG001'}, {'value': '72.0', 'groupId': 'OG002'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}, {'value': '12.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)', 'description': 'An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized subjects who received at least 1 dose of IMP.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 (Day 1) in SF-36 Components at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'title': 'Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '7.95', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '7.57', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '10.33', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '12.01', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '9.08', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '11.44', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '9.30', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '8.42', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '8.62', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '10.26', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '8.64', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '9.51', 'groupId': 'OG002'}]}]}, {'title': 'Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '9.30', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '10.72', 'groupId': 'OG002'}]}]}, {'title': 'General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '8.43', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '7.72', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '8.00', 'groupId': 'OG002'}]}]}, {'title': 'Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '9.86', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '9.76', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '9.57', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '11.45', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '10.06', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '11.08', 'groupId': 'OG002'}]}]}, {'title': 'Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '12.71', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '10.43', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '10.99', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '12.30', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '8.87', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '10.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 (Day 1) and Week 24', 'description': 'The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here "Number Analyzed" signifies those subjects who were evaluable for this outcome measure at specified categories.'}, {'type': 'POST_HOC', 'title': 'High Disease Activity Subpopulation (SLEDAI-2K >=10 at Screening): Logistic Regression of Percentage of Subjects With SRI-6 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000'}, {'value': '54.9', 'groupId': 'OG001'}, {'value': '28.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0048', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.31', 'ciLowerLimit': '1.44', 'ciUpperLimit': '7.61', 'statisticalMethod': 'Logistic regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "SRI-6 response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\\>=) 6 points; no significant worsening in Physician's Global Assessment (PGA) score (\\<10 % increase, defined as \\<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \\<=1 (defined as no more than one) new BILAG B organ domain score. Logistic regression of number of subjects with SRI-6 response was analyzed by using Logistic regression model.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT\\_HDA analysis set included mITT population with high disease activity (HDA) defined as screening SLE Disease Activity Index (SLEDAI) \\>=10.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}, {'value': '55.8', 'groupId': 'OG001'}, {'value': '41.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0202', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '1.11', 'ciUpperLimit': '3.46', 'statisticalMethod': 'Logistic regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\\<10 % increase, defined as \\<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \\<=1 (defined as no more than one) new BILAG B organ domain score.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'FG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Other events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The study was conducted at 136 sites in 18 countries in Asia, Europe, North America, Central America, and South America.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '306', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Atacicept 75 mg', 'description': 'Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'BG001', 'title': 'Atacicept 150 mg', 'description': 'Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '39', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '40', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '39', 'spread': '11.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '280', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified intent-to-treat (mITT) analysis set included all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2013-10-24', 'resultsFirstSubmitDate': '2017-09-29', 'studyFirstSubmitQcDate': '2013-10-24', 'lastUpdatePostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-29', 'studyFirstPostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline', 'timeFrame': 'Week 24', 'description': "SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\\<10 % increase, defined as \\<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \\<=1 (defined as no more than one) new BILAG B organ domain score."}, {'measure': 'Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline', 'timeFrame': 'Week 24', 'description': "SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\\<10 % increase, defined as \\<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \\<=1 (defined as no more than one) new BILAG B organ domain score."}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity', 'timeFrame': 'Week 24', 'description': 'BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone \\>20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.'}, {'measure': 'Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24', 'timeFrame': 'Week 24', 'description': "The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented."}, {'measure': 'Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24', 'timeFrame': 'Screening and Week 24', 'description': 'Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.'}, {'measure': 'Time From Randomization to First SRI Response During Treatment Period', 'timeFrame': 'Baseline up to 24 Weeks', 'description': "SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\\<10 % increase, defined as \\<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \\<=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented."}, {'measure': 'Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24', 'timeFrame': 'Week 24', 'description': 'The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and \\<=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by \\<10% (defined as \\<0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.'}, {'measure': 'Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)', 'description': 'An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.'}, {'measure': 'Change From Week 0 (Day 1) in SF-36 Components at Week 24', 'timeFrame': 'Week 0 (Day 1) and Week 24', 'description': 'The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.'}]}, 'conditionsModule': {'keywords': ['Atacicept', 'Placebo'], 'conditions': ['Lupus Erythematosus, Systemic']}, 'referencesModule': {'references': [{'pmid': '37332136', 'type': 'DERIVED', 'citation': 'Pitsiu M, Yalkinoglu O, Farrell C, Girard P, Vazquez-Mateo C, Papasouliotis O. Population pharmacokinetics of atacicept in systemic lupus erythematosus: An analysis of three clinical trials. CPT Pharmacometrics Syst Pharmacol. 2023 Aug;12(8):1157-1169. doi: 10.1002/psp4.12982. Epub 2023 Jun 18.'}, {'pmid': '32107560', 'type': 'DERIVED', 'citation': 'Morand EF, Isenberg DA, Wallace DJ, Kao AH, Vazquez-Mateo C, Chang P, Pudota K, Aranow C, Merrill JT. Attainment of treat-to-target endpoints in SLE patients with high disease activity in the atacicept phase 2b ADDRESS II study. Rheumatology (Oxford). 2020 Oct 1;59(10):2930-2938. doi: 10.1093/rheumatology/keaa029.'}, {'pmid': '29073347', 'type': 'DERIVED', 'citation': 'Merrill JT, Wallace DJ, Wax S, Kao A, Fraser PA, Chang P, Isenberg D; ADDRESS II Investigators. Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase IIb Study. Arthritis Rheumatol. 2018 Feb;70(2):266-276. doi: 10.1002/art.40360.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible male and female subjects, aged 18 years or older\n* Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to \\[\\>=\\] 6 at screening visit\n* At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed \\>= 6 months prior to the screening visit)\n* Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Subjects have demyelinating disorder\n* Severe central nervous system SLE\n* Use of cyclophosphamide within 3 months of the screening visit\n* Urine protein:creatinine ratio (UPCr) \\>= 2 milligram per milligram (mg/mg) per day\n* Other protocol defined exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT01972568', 'acronym': 'ADDRESS II', 'briefTitle': 'Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': 'A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)', 'orgStudyIdInfo': {'id': '700461-023'}, 'secondaryIdInfos': [{'id': '2013-002773-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atacicept 75 mg', 'interventionNames': ['Drug: Atacicept 75 milligram (mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Atacicept 150 mg', 'interventionNames': ['Drug: Atacicept 150 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atacicept 75 milligram (mg)', 'type': 'DRUG', 'description': 'Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.', 'armGroupLabels': ['Atacicept 75 mg']}, {'name': 'Atacicept 150 mg', 'type': 'DRUG', 'description': 'Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.', 'armGroupLabels': ['Atacicept 150 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group LLC', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham - (UAB)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92806', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Wallace Rheumatic Study Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Rheumatology Medical Group, Inc.', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '34698', 'city': 'Dunedin', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida - Corporate', 'geoPoint': {'lat': 28.0199, 'lon': -82.77323}}, {'zip': '33309', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Rheumatology, Immunology & Arthritis', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida, Inc.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Goldpoint Clinical Research, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'facility': 'AA MRC LLC Ahmed Arif Medical Research Center', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North MS Medical Clinics, Inc.', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers New Jersey Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11031', 'city': 'Manhasset', 'state': 'New York', 'country': 'United 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39.75895, 'lon': -84.19161}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Arthritis & Rheumatology Center of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OMRF', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research Center of Reading LLC', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina (MUSC)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'UTMB Pathology Clinical Services', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '76708', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Arthritis & Osteoporosis Clinic', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '24541', 'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Danville Orthopedic Clinic, Inc.', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}, {'city': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina', 'facility': 'APRILLUS'}, {'city': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina', 'facility': 'Atencion Integral en Reumatologia (AIR)'}, {'city': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano'}, {'city': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina', 'facility': 'Organizacion Medica de Investigacion (OMI)'}, {'city': 'Mar del Plata', 'country': 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